- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT00719446
Evaluating Health Outcomes and QOL After ALI Among Participants of the ALTA, OMEGA, EDEN, and SAILS ARDS Network Trials (ALTOS)
Patient Outcomes 6 and 12 Months After ALTA, OMEGA, EDEN and SAILS ARDS Network Trials
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
ALI, a life-threatening condition that involves inflammation of the lungs and fluid accumulation in the air sacs, typically leads to low blood oxygen levels and respiratory failure. Common causes of ALI include pneumonia, sepsis, and lung trauma. Symptoms, including breathing difficulty, low blood pressure, and organ failure, usually develop within 24 to 48 hours of the original injury or illness. Most patients require immediate care in an intensive care unit (ICU), and the main form of treatment is mechanical ventilation, which delivers oxygen and a continuous level of pressure to the damaged lungs. The ARDS Network (ARDSNet) is a group of hospitals and medical centers that conduct research to improve treatment options for people with ARDS and ALI. This study will enroll people who participated in the ARDSNet's ALTA, OMEGA, EDEN, or SAILS study; these studies are investigating new treatments to improve survival and reduce the amount of time people remain on mechanical ventilation in the ICU after ALI. It is not known whether the ARDSNet's treatments have any prolonged benefit for patients after they leave the hospital. The purpose of this study is to evaluate participants' quality of life and long-term health outcomes after they receive the ALTA, OMEGA, EDEN, or SAILS study treatments.
This study will enroll participants who were in the ALTA, OMEGA, EDEN, or SAILS study. ARDS Network trial participants from sites that approved this follow-up study will be contacted by phone at 6 and 12 months to complete a collection of surveys. These surveys assess quality of life, mental health, memory and cognition, physical functioning, fatigue, employment and health insurance status, and health care utilization. At the end of each follow-up, participants will be asked for feedback regarding their experience during the follow-up.
For participants from a sub-set of ARDS Network study sites participating in this study, researchers will review participants' medical records and information collected during the ARDSNet studies. Six and 12 months after ALI, participants will attend study visits at which time walking ability, lung function, and muscle strength will be measured. Weight, dietary changes, and changes in muscle and fat composition will also be assessed. Participants will take part in interviews to evaluate memory and cognition. If participants cannot attend the study visits, research staff will either visit participants' homes to complete the evaluations or conduct some of the evaluations over the phone.
Studientyp
Einschreibung (Tatsächlich)
Kontakte und Standorte
Studienorte
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Maryland
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Baltimore, Maryland, Vereinigte Staaten, 21205
- Johns Hopkins University
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Baltimore, Maryland, Vereinigte Staaten, 21201
- University of Maryland Medical Center
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North Carolina
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Winston Salem, North Carolina, Vereinigte Staaten, 27157
- Wake Forest University
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Tennessee
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Nashville, Tennessee, Vereinigte Staaten, 37232
- Vanderbilt University
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Utah
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Murray, Utah, Vereinigte Staaten, 84107
- Intermountain Medical Center
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Washington
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Seattle, Washington, Vereinigte Staaten, 98104
- University of Washington/Harborview Medical Center
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
Beschreibung
Inclusion Criteria:
- Participated in the ALTA, EDEN, OMEGA, or SAILS study
- Survived until hospital discharge
Exclusion Criteria:
- Does not understand or speak English
- Has no fixed address
- Pre-existing cognitive impairment that prevents completion of the study assessments
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
---|---|
Individual Physical Function and Mental Health domains from SF-36 (for participants who complete the phone surveys); 6-minute walk distance and memory evaluation (for participants who attend the study visits)
Zeitfenster: Measured at Months 6 and 12
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Measured at Months 6 and 12
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Quality of life, mental health, memory and cognition, physical functioning, fatigue, walking ability, lung function, muscle strength, weight, dietary changes, and changes in muscle and fat composition
Zeitfenster: Measured at Months 6 and 12
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Short Form-36 domains, EQ-5D, Hospital Anxiety and Depression Scale, Impact of Event Scale-Revised, Mini-Mental State Examination, FACIT-Fatigue, Functional Performance Inventory, Wechsler Memory Scale - Logical Memory 1/2, Wechsler Adult Intelligence Scale - Digit Span and Similarities, Controlled Oral Word Association Test, Hayling Sentence Completion, Cognistat - Orientation and Judgment, Timed 4 Meter Walk, Hand grip, Manual Muscle Test, Maximal Inspiratory Pressure, Anthropometrics, DEXA
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Measured at Months 6 and 12
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Andere Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
---|---|
Health Care Utilization, Employment Status, Health Insurance Status
Zeitfenster: Measured at Months 6 and 12
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Measured at Months 6 and 12
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Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Dale M. Needham, MD, PhD, Johns Hopkins University
- Hauptermittler: Ramona O Hopkins, PhD, Intermountain Medical Center
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- Brown SM, Wilson E, Presson AP, Zhang C, Dinglas VD, Greene T, Hopkins RO, Needham DM; with the National Institutes of Health NHLBI ARDS Network. Predictors of 6-month health utility outcomes in survivors of acute respiratory distress syndrome. Thorax. 2017 Apr;72(4):311-317. doi: 10.1136/thoraxjnl-2016-208560. Epub 2016 Jul 20.
- Dinglas VD, Hopkins RO, Wozniak AW, Hough CL, Morris PE, Jackson JC, Mendez-Tellez PA, Bienvenu OJ, Ely EW, Colantuoni E, Needham DM. One-year outcomes of rosuvastatin versus placebo in sepsis-associated acute respiratory distress syndrome: prospective follow-up of SAILS randomised trial. Thorax. 2016 May;71(5):401-10. doi: 10.1136/thoraxjnl-2015-208017. Epub 2016 Mar 2.
- Needham DM, Colantuoni E, Dinglas VD, Hough CL, Wozniak AW, Jackson JC, Morris PE, Mendez-Tellez PA, Ely EW, Hopkins RO. Rosuvastatin versus placebo for delirium in intensive care and subsequent cognitive impairment in patients with sepsis-associated acute respiratory distress syndrome: an ancillary study to a randomised controlled trial. Lancet Respir Med. 2016 Mar;4(3):203-12. doi: 10.1016/S2213-2600(16)00005-9. Epub 2016 Jan 29.
- Dinglas VD, Huang M, Sepulveda KA, Pinedo M, Hopkins RO, Colantuoni E, Needham DM; NIH NHLBI ARDS Network. Personalized contact strategies and predictors of time to survey completion: analysis of two sequential randomized trials. BMC Med Res Methodol. 2015 Jan 9;15:5. doi: 10.1186/1471-2288-15-5.
- Needham DM, Dinglas VD, Bienvenu OJ, Colantuoni E, Wozniak AW, Rice TW, Hopkins RO; NIH NHLBI ARDS Network. One year outcomes in patients with acute lung injury randomised to initial trophic or full enteral feeding: prospective follow-up of EDEN randomised trial. BMJ. 2013 Mar 19;346:f1532. doi: 10.1136/bmj.f1532.
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 589
- R01HL091760 (US NIH Stipendium/Vertrag)
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